7. Drug & Device Updates


FDA approves Kerendia to reduce risk of serious kidney and heart complications in people with T2D

FDA approves Kerendia to reduce risk of serious kidney and heart complications in people with T2D

      FDA had approved Kerendia (finerenone) tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes. The efficacy of Kerendia to improve kidney and heart outcomes was evaluated in a randomized, multicenter, double-blind, placebo-controlled study in adults with chronic kidney disease associated with type 2 diabetes.

In this study, 5,674 patients were randomly assigned to receive either Kerendia or a placebo. Results showed that 504 of the 2,833 patients who received Kerendia had at least one of the events in the composite endpoint compared to 600 of the 2,841 patients who received a placebo. The drug is found to reduce the risk of cardiovascular death, non-fatal heart attack, and hospitalization for heart failure as well. FDA granted the approval of Kerendia to Bayer Healthcare.

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Sotagliflozin reduces heart attack, heart failure and stroke in diabetics

Sotagliflozin reduces heart attack, heart failure and stroke in diabetics

      Sotagliflozin, a drug that inhibits sodium-glucose transport protein (SGLT 2) and sodium-glucose transport protein (SGLT 1) is now found to be associated with reducing the risk of heart attack, heart failure and stroke in individuals with diabetes. Paired analysis of two large clinical trials SCORED and SOLOIST had revealed these findings. The SCORED trial found that SGLT1/2 inhibitors provide benefits across the full range of albuminuria, a sign of kidney disease that involves an excess of protein in urine, and decrease the chance of heart attack by 32% and of stroke by 34%.

The SOLOIST trial revealed that SGLT1/2 inhibitors are safe and effective when initiated in patients hospitalized with acute heart failure and early in-hospital initiation of SGLT2 inhibitors is safe and effective for people with type 2 diabetes and heart failure, reducing the risk of death from cardiovascular causes and hospitalization or urgent visits for heart failure by 33% respectively. The findings were published in the New England Journal of Medicine.

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Tirzepatide reduces weight gain and improves HbA1c

Tirzepatide reduces weight gain and improves HbA1c

      Tirzepatide is a novel, once-weekly injectable dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that integrates the actions of the GIP and GLP-1 incretins into a single molecule, represents a new class of medicines for the treatment of type 2 diabetes. SURPASS trials were designed to provide insights into tirzepatide's potential for the treatment for type 2 diabetes. SURPASS-1 evaluated the efficacy and safety of three tirzepatide doses (5 mg, 10 mg, and 15 mg) as monotherapy against placebo among people with type 2 diabetes. SURPASS-2 and SURPASS-3 compared the efficacy and safety of the same three doses of tirzepatide to injectable semaglutide 1 mg and insulin degludec, respectively. SURPASS-5 evaluated the efficacy and safety of tirzepatide as an add-on to insulin glargine compared to placebo. Recent data from the trial demonstrate statistically significant A1c and weight reductions. Tirzepatide is under development and in phase three of clinical trials for the treatment of type 2 diabetes.

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The Future wave of glucose technology in diabetes care

The Future wave of glucose technology in diabetes care

      Two researchers from Israel Dr. Waintraub and Major General Guy Zur had developed a novel noninvasive technology, GWave that relies on artificial intelligence and physics. According to the GWave developers, the technology has conducted about 15,000 separate blood sugar measurements on people in controlled settings.

In its first pilot study, fifty measurements were taken on five patients, and the results revealed that GWave had performed exceptionally well as compared with core laboratory glucose measurements and needless to say that recording 100 percent of the noninvasive readings within 10% of the reference method used for calibration (Abbott FreeStyle [finger sticks]). The advantages of GWave are more convenient and less intrusive than CGM, more accurate as it measures capillary blood glucose and does not require calibrations. GWave would be applicable not only to people with type 1 and type 2 diabetes but to the pre-diabetes population as well.

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